OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
19 Oct 2023
19 Oct 2023
Historique:
medline:
23
10
2023
pubmed:
27
8
2023
entrez:
27
8
2023
Statut:
ppublish
Résumé
Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).
Sections du résumé
BACKGROUND
BACKGROUND
Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain.
METHODS
METHODS
We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.
RESULTS
RESULTS
We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group.
CONCLUSIONS
CONCLUSIONS
Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).
Identifiants
pubmed: 37634149
doi: 10.1056/NEJMoa2307770
doi:
Banques de données
ClinicalTrials.gov
['NCT03171311']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1477-1487Investigateurs
Evald Høj Christiansen
(EH)
Jacob Thomsen Lønborg
(JT)
Lisette Okkels Jensen
(L)
Ole Havndrup
(O)
Niels Thue Olsen
(NT)
Ashkan Eftekhari
(A)
Christian Eek
(C)
Pavel Hoffmann
(P)
Slobodan Calic
(S)
Øyvind Bleie
(Ø)
Matthias Heigert
(M)
Nils Witt
(N)
Irene Santos-Pardo
(I)
Loghman Henareh
(L)
Jacob Odenstedt
(J)
Fredrik Calais
(F)
Peep Laanmets
(P)
Olli Kajander
(O)
Andrew McNeice
(A)
James Cockburn
(J)
James Spratt
(J)
Daniel R Obaid
(DR)
Peter O'Kane
(P)
Saqib Chowdhary
(S)
Stuart Watkins
(S)
Darren Mylotte
(D)
Indulis Kumsars
(I)
Stephan Kische
(S)
Matthias Lutz
(M)
Martin W Bergmann
(MW)
Peter Clemmensen
(P)
Francesco Burzotta
(F)
Simone Biscaglia
(S)
Paul Knaapen
(P)
Leo Timmers
(L)
Ton Heestermans
(T)
Johan Bennett
(J)
Jo Dens
(J)
Lukasz Koltowski
(L)
Niels Ramsing Holm
(NR)
Helle Bargsteen
(H)
Helle Pagh Pedersen
(H)
Hanne Winchkler
(H)
Mona Jørgensen
(M)
Pia Ottesen
(P)
Lars Jørgensen
(L)
Omeed Neghabat
(O)
Lene Nyhus Andreasen
(LN)
Lone Juul Hune Mogensen
(LJH)
Morten Madsen
(M)
Jakob Hjort
(J)
Martin Rahbek
(M)
Miquel Santos Llinas
(M)
Søren-Haldur Bülow Rasmussen
(SH)
Kenneth Spure Nielsen
(KS)
Ruthe Storgaard Dieu
(RS)
Andreas Torp Andreas
(AT)
Pia Stycke Ottosen
(P)
Jan Ravkilde
(J)
Kristian Thygesen
(K)
Tommy Liu
(T)
Kjeld Nukus
(K)
Jacek Legutko
(J)
Andrew Ladwiniec
(A)
Roberto Scarsini
(R)
Juha Hartikainen
(J)
Tom Johnson
(T)
David Erlinge
(D)
Informations de copyright
Copyright © 2023 Massachusetts Medical Society.